Accurate Controlled Dental Sedation

NCT ID: NCT00963898

Last Updated: 2009-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-08-31

Brief Summary

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The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.

Detailed Description

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The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.

Conditions

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Mental Retardation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mental Retardation

Group Type EXPERIMENTAL

Target controlled infusion(TCI), Bispectral index(BIS)

Intervention Type DEVICE

Using TCI and BIS or not

Interventions

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Target controlled infusion(TCI), Bispectral index(BIS)

Using TCI and BIS or not

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Participants aged 16 or over,
2. American Society of Anesthesiologists (ASA) physical status 1 or 2
3. The treatments of dental caries, endodontics, periodontics and prosthesis were planed
4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria

1. Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons,
2. Patients needed premedication
3. Patients had uncontrolled or sever medical condition
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Okayama University

OTHER

Sponsor Role lead

Responsible Party

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Okayama University Hospital

Principal Investigators

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Hitoshi Higuchi, D.D.S., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Okayama University

Locations

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Department of Dental Anesthesiology, Okayama University Hospital

Okayama, Okayama-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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1104mai

Identifier Type: -

Identifier Source: org_study_id

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